Dry granulation process modeling

Abstract : Dry granulation is a powder agglomeration process used in the pharmaceutical industry to improve the flowability of powders by increasing the particle size (granules). This operation is achieved using a roller press, which can have different configurations and equipment designs. Progress in experimental investigations has allowed confirming the impact of the process on granules properties and tableting, however full understanding of the process remains difficult. The development of a predictive model for roller compaction is promising to provide insight and to allow significantly advance the understanding and design of the process. In this work, a review of existing modeling and experimental validations are reported and discussed. The main focus was on the modeling of the process using the finite element method (FEM). It was demonstrated that FEM modeling of the roller compaction process offers a versatile approach to bring guidance and practical solutions that can be used to optimize design and process development. However, currently there is a lack of experimental information under relevant process conditions to improve the quality of predictions. Only few and partial experimental validations of two-dimensional and three-dimensional FEM for modeling pharmaceutical applications have been attempted.